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NOT YET RECRUITING
NCT07759817
NA

Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment Areas

Sponsor: FA Corporation

View on ClinicalTrials.gov

Summary

This study evaluates the safety and effectiveness of the UltraClear® 2,910 nm fractional ablative fiber laser for improving skin laxity and tissue lifting in the lower face, submental, and neck areas. Up to 50 adults ages 35-65 will receive two laser treatments approximately 7 weeks apart at two clinical sites. Outcomes will be assessed approximately 90 days after the second treatment using photographic analysis and investigator- and participant-reported improvement scales.

Key Details

Gender

All

Age Range

35 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-08-07

Completion Date

2027-08-31

Last Updated

2026-08-12

Healthy Volunteers

Yes

Interventions

DEVICE

2910 nm fiber laser (UltraClear®)

UltraClear® is a 2,910 nm fractional ablative erbium-doped fluoride glass fiber laser (Acclaro), FDA 510(k) cleared (K210847, K233803) for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. In this study, it is applied to the lower face, submental region, and neck using fractional ablative resurfacing, laser-coring, and full ablative resurfacing configurations, with mode and parameters selected by the investigator based on baseline anatomy and tissue laxity.

Locations (2)

Julene B Samuels MD, FACS

Prospect, Kentucky, United States

Dermatology & Laser Surgery Center

Houston, Texas, United States